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ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00975507
First received: September 10, 2009
Last updated: April 21, 2010
Last verified: April 2010
History of Changes
  Purpose

This study will compare Measles, Mumps, Rubella, and Varicella Vaccine (V221) and concomitant administration of Varivax and M-M-R II vaccines in healthy children.


Condition Intervention Phase
Measles
Mumps
Rubella
Varicella
 Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
Biological: Comparator: Placebo
Biological: Comparator: Varivax
Biological: Comparator: M-M-R II
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Pilot Study to Compare the Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine and the Concomitant Administration of the Currently Licensed VARIVAX™ and M-M-R II™ in Healthy Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline [ Time Frame: 6 weeks Postvaccination ] [ Designated as safety issue: No ]
    Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of <0.6 gpELISA units/mL) to Varicella at Baseline


Secondary Outcome Measures:
  • Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL [ Time Frame: 6 weeks Postvaccination ] [ Designated as safety issue: No ]
    Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <207.8 mIU/mL) to Measles at Baseline

  • Number of Participants With Postvaccination Varicella Antibody Titer ≥5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline [ Time Frame: 6 weeks Postvaccination ] [ Designated as safety issue: No ]
    Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline

  • Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL [ Time Frame: 6 weeks Postvaccination ] [ Designated as safety issue: No ]
    Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <2.0 Ab Units/mL) to Mumps at Baseline

  • Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL [ Time Frame: 6 weeks Postvaccination ] [ Designated as safety issue: No ]
    Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline


Enrollment: 480
Study Start Date: March 1998
Study Completion Date: June 1999
Primary Completion Date: January 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ProQuad™ (V221) + Placebo Followed by ProQuad™
 Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
a single 0.5 mL subcutaneous injection of V221 at Day 0 and Day 90
Other Name: ProQuad™
Biological: Comparator: Placebo
a single 0.5 mL subcutaneous placebo injection at Day 0
Active Comparator: 2
M-M-R™ II + VARIVAX™
 Biological: Comparator: Varivax
a single 0.5 mL subcutaneous injection of Varivax at Day 0
Biological: Comparator: M-M-R II
a single 0.5 mL subcutaneous injection of M-M-R II at Day 0

  Eligibility

Ages Eligible for Study:   12 Months to 23 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • In good health
  • Negative clinical history of varicella, shingles, measles, mumps, and rubella

Exclusion Criteria:

  • Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination
  • Any immune impairment or deficiency
  • Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination
  • Vaccination with an inactive vaccine with in the past 14 days
  • Vaccination with a live vaccine within the past 30 days
  • Immune globulin or any blood product administered in the past 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00975507

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00975507     History of Changes
Other Study ID Numbers: 2009_660, V221-009
Study First Received: September 10, 2009
Results First Received: September 23, 2009
Last Updated: April 21, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Measles
Mumps
Rubella
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Morbillivirus Infections
Paramyxoviridae Infections
 Mononegavirales Infections
RNA Virus Infections
Rubulavirus Infections
Parotitis
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Rubivirus Infections
Togaviridae Infections

ClinicalTrials.gov processed this record on May 23, 2013